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Clinical Research Solutions

Biotech Startup Approaching IND: 5 Mistakes to Avoid While Writing a Development Plan

In the drug development process, the Investigational New Drug (IND) application holds immense significance for biotech startups. It serves as a comprehensive overview submitted to the US Food and...

Clinical Research Solutions

What You Need to Know About CBER Pre-IND Meetings

The FDA provides several opportunities to hold meetings with Sponsors to gain clarification and agreement on the development of medicinal products. At the preliminary stages of development, one such...

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Clinical Research Solutions

FDA Issues Revised Draft Guidance on Charging for Investigational Drugs Under an Investigational New Drug Application

August 2022 Draft Guidance This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on...

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Clinical Research Solutions

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry

Guidance Document August 2022 This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt...

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Clinical Research Solutions

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry

Final Guidance July 2022 This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications...

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Clinical Research Solutions

Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry

Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...

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Clinical Research Solutions

How to Interpret FDA’s Final Guidance - “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”

On June 23, 2022, The FDA issued the final version of its Guidance for Industry titled “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”. The most...

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Clinical Research Solutions

Use of Circulating Tumor Deoxyribonucleic Acid for Early-Stage Solid Tumor Drug Development; Draft Guidance for Industry; Availability

May 2022 Guidance Document Download the Final Guidance Document The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of...

Clinical Research Solutions

FDA releases Guidance for Industry on Bioavailability Studies Submitted in NDAs or INDs — General Considerations

FDA issued a final guidance to drug sponsors on conducting and submitting bioavailability (BA) studies for drug products in investigational new drug applications (INDs), new drug applications (NDAs),...

Clinical Research Solutions

FDA Sets A Deadline For Electronic Submission Of Drug Applications

In a final guidance published in the Federal Register on May 5, FDA laid out the rules and specifications for providing regulatory submissions in electronic format. Perhaps more important than the...